and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating Organizations
National Institutes of Health
(NIH) ( http://www.nih.gov)
Components of Participating Organizations
National Institute of Mental
Health (NIMH) ( http://www.nimh.nih.gov)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)
Title: Research On The Reduction And
Prevention Of Suicidality (R01)
Announcement Type
This is a reissue of PA-03-161, which was previously issued on August 7, 2003.
Update: The following update relating to this announcement has been issued:
Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.
Program
Announcement (PA) Number: PA-06-438
Catalog of Federal Domestic Assistance Number(s)
93.242, 93.279, 93.891,
93.866, 93.393
Key Dates
Release Date: June 2,
2006
Application Submission
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for
details.
AIDS Application Receipt Date(s): Not applicable.
Peer Review Date(s):See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review
Date(s):See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated
Start Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information
To Be Available Date (Url Activation Date): Not applicable.
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible
Institutions
B. Eligible
Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and
Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
PURPOSE OF THIS FUNDING OPPORTUNITY ANNOUNCEMENT (FOA)
The National Institute of Mental Health (NIMH), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Institute on Drug Abuse (NIDA) invite grant applications for research that will reduce the burden of suicidality (deaths, attempts, and ideation). While NIMH has a long-standing commitment to studying the mental health-related factors contributing to suicide risk, NIDA, and NIAAA supported research in suicidality is growing and has provided a broader perspective on the range of risk and protective factors. For this FOA, mental disorders, along with alcohol use disorders (AUDs) and substance use disorders (SUDs) and their respective trajectories, are of particular interest as they pertain to risk and protective factors and treatment efficacy and effectiveness for suicidality. The intent of the funding opportunity announcement is to intensify investigator-initiated research on this topic, to attract new investigators to the field, and increase interdisciplinary approaches to developing effective strategies to reduce suicidality.
RESEARCH OBJECTIVES
Background
In 2003, 31,484 persons died by suicide in the United States. Suicide deaths outnumbered homicide deaths by nearly 2 to 1. Suicide was the third leading cause of death for 10-24 year olds, and the eighth leading cause of death for males. Vital statistics indicate that suicide rates vary dramatically by demographic characteristics. Males die by suicide more frequently than females by a ratio of 4 to 1. Older white males have the highest suicide rate, followed by young American Indian and Native Alaska males. In contrast, vital statistics data indicate that older African American females have one of the lowest rates. Married persons have lower rates than unmarried persons. Rural suicide rates exceed those in urban areas, and state rates vary by region, with Western mountain states having the highest suicide rates in the Nation. A number of U.S. Territories have suicide rates that exceed many U.S. state rates.
The health conditions most consistently associated with suicide are mental illness, SUDs and AUDs, affecting up to 90% of all people who die by suicide. The lifetime risk for suicide death among alcohol-dependent individuals has been estimated to be 7 to 10%, and among persons with affective disorders, 2 to 7%. Family history of suicide, and an individual's prior history of suicide attempts and serious ideation are also significantly associated with subsequent suicide death. Despite these strong associations, only a small proportion of persons with these disorders and family history die by suicide, raising important questions regarding what protective factors operate among persons with multiple risk factors. Most medical illnesses are not associated with an increased risk for suicide. However, individuals diagnosed with HIV/AIDS, multiple sclerosis, or brain cancers have been found to have increased risk for suicide.
Suicide attempts and serious suicide ideation (e.g., thoughts that include suicide plans), each more frequent than suicide deaths, also carry a substantial health burden. In 2002, 132,353 individuals were hospitalized following suicide attempts and 116,639 were treated in emergency departments and released. Another estimated 50 percent of persons who attempt suicide do not seek treatment. In addition to the burden from physical harm consequent to the behavior, suicide attempts are associated with an increase in the risk of later suicide death by 40-fold. Persons with mental disorders, SUDs and AUDs have increased risk for suicide attempts. Intentional overdose with drugs of abuse or prescription drugs is a common method of suicide attempt, particularly among women. Persons with AUD and a history of an attempt have a greater than 20-fold increased risk for subsequent suicide death. Among alcohol-dependent individuals, those with a history of suicide attempts are more often female, younger, currently unemployed, separated or divorced, and have fewer years of education. Serious suicide ideation is more frequent among youth than adults, and is associated with other high-risk behaviors. Annual surveys indicate that 1 in 5 high school students report suicide ideation in the past year.
There have been substantial strides in our understanding of suicide risk factors, and early progress in clinical trials focused on reducing suicidal behaviors per se. Research in this area has been invigorated further by the recognition that suicidality, with its related mortality and morbidity, represents a significant, and usually preventable loss of human life. A number of recent federal, national and international reports have proposed a public health framework from which to develop strategies to reduce known risk factors and increase protective factors. The reports include those from the World Health Organization (http://www5.who.int/violence_injury_prevention/main.cfm?p=0000000117), the National Strategy for Suicide Prevention (http://www.mentalhealth.org/suicideprevention/default.asp), an IOM report (http://www.nap.edu/books/0309083214/html/)), and various Surgeon General's Reports on suicide
(http://www.surgeongeneral.gov/library/calltoaction/default.htm) and mental health (http://www.surgeongeneral.gov/library/mentalhealth/home.html) and (http://www.surgeongeneral.gov/library/mentalhealth/cre/). This funding opportunity announcement highlights areas of research that can facilitate the development, implementation, and/or testing of interventions that show promise in preventing and reducing suicidality.
Areas of Research Opportunities
Investigators are advised to carefully consider definitions of suicidality (see O'Carroll, et al. (1996), Beyond the Tower of Babel: A Nomenclature for Suicidology, Suicide & Life-Threatening Behavior, 26 (3), 237-252) and approaches to measurement (see http://www.nimh.nih.gov/research/measures.pdf and http://www.nimh.nih.gov/research/adultsuicide.pdf), theoretical models of distal and proximal risk and protective factors, and models of behavioral and social change that have implications for reducing suicide risk.
a. Risk and Protective Factors
Psychological and Cultural Factors. Much has been learned about suicidality and associated psychological risk factors including hopelessness, shame, and the significance of stressful life events such as physical, psychological and sexual abuse, and interpersonal and financial losses. Less understood are other risk and protective factors and their interactions, such as, but not limited to:
Biological and Genetic Factors. Various neurobiological abnormalities including differences in serotonin receptor and noradrenergic system abnormalities have been linked to suicide death and attempts. There are estimates that the heritability of liability to suicidal behavior ranges from 30-50 percent, and this high loading is likely due to the potential contributions of multiple genes, in addition to shared family environments that include living with mental disorders and stressful life events. Research efforts to partition suicide risk to various genetic and neurobiological abnormalities have been limited by the short supply of characterized populations at high risk for suicide, as well as the low availability of autopsied brains of suicide victims. Studies of biological and genetic factors include, but are not limited to:
b. Clinical Trials
The established efficacy of most treatments for mental disorders is based on data from individuals at low risk for suicidal behavior. With the exception of the clozapine indication for reduction of suicidality among persons with schizophrenia, and observational studies of lithium that suggest a reduced suicide risk among persons with bipolar disorder, no psychotropic medications have been studied to determine whether they are effective in reducing suicidality in randomized trials. About 40% of treatment-seeking AUD patients report a history of attempting suicide. Several psychosocial and behavioral interventions targeting suicidality, provided in consort with treatments for mental disorders and SUDs, are showing promise with 50% reduction in re-attempts within a year. Sample topics include, but are not limited to:
c. Multi-level Prevention Approaches
The IOM report, Reducing Suicide, highlighted the particular challenges in assessing population-based prevention approaches due to the relatively low base rate of suicide deaths, and the limited prevalence data on suicide attempts and ideations. However, it also highlighted the opportunities to examine whether the substantial number of preventive interventions that have proved successful in reducing early substance use, drinking and driving, binge drinking, and aggression, also reduce suicidality. These intervention approaches are developmentally specific and wide-ranging; involving parents, extended families, health professionals, schools, worksites and employee assistance programs, and community agencies and task forces. Including suicidality outcomes in these preventive intervention investments would be an efficient means of testing the potential power of these approaches in reducing suicide risk. Similarly, suicidality prevention and treatment interventions for youth may also confer some protection from involvement with alcohol and other substances. Other preventive intervention opportunities include, but are not limited to:
Where risk of suicide is excessively high in particular communities (e.g., some American Indian tribes), it may be appropriate to approach the problem simultaneously at universal, selective, and indicated levels. The use of community-based participatory research could be used to adapt interventions for subpopulations within the community according to their relative risk and the intensity of their interactions with vulnerable individuals.
d. Services Research
Due to the lack of empirically-based assessment and treatment approaches to reducing suicidality, there are few practice guidelines to implement to improve the quality of care provided in emergency, specialty, or primary care sectors. Alternatively, there may be helpful practice policies that are not adequately implemented, while other policies may unintentionally limit efforts to provide better care. Topics include, but are not limited to:
e. Contagion, Media Campaigns, and Health Education
Public health approaches have used mass-media campaigns to varying success to reduce smoking, alcohol and other substance use, but few evaluation efforts have been implemented to test campaigns to reduce suicide. Evidence of suicide contagion from media coverage of youth suicide deaths has been one reason for concern in mounting broad campaigns. If the National Strategy for Suicide Prevention is to be adequately implemented, safe approaches to building awareness in the public about suicide and its risk factors must be developed. Examples of relevant goals include, but are not limited to:
f. Ethical and Safety Issues
Examples of relevant research goals include, but are not limited to:
Research to elucidate the purported link between antidepressant treatment and suicidality, including:
Other institutes and agencies with relevant resources and related interests:
The Substance Abuse and Mental Health Services Administration (SAMHSA) Office of Applied Studies supports surveys assessing prevalence of suicidality among persons meeting criteria for major depressive episode in the past year, and related risk factors (see http://www.drugabusestatistics.samhsa.gov/). SAMHSA's Center for Mental Health Services supports the National Suicide Prevention Resource Center (see: http://www.sprc.org), the National Suicide Strategy Indicators project (see http://www.nsspi.org) as well as demonstration programs in the prevention and treatment of mental and substance abuse disorders, including suicide prevention. Investigators may be interested in the availability of the National Suicide Prevention Lifeline (see http://www.suicidepreventionlifeline.org). The Garrett Lee Smith Memorial Act has authorized SAMHSA to support a number of suicide prevention-relevant demonstration grants for high school and college age youth. These and additional demonstration funding opportunities can be found at http://www.samhsa.gov/.
The Centers for Disease Control and Prevention's (CDC) National Center for Injury Prevention and Control (NCIPC), focuses on addressing the need for effective, population-based prevention and intervention strategies regarding self-directed violence. NCIPC's activities fall into four categories: disseminating information about suicidal behavior and its prevention and supporting the implementation of proven programs and policies; applying scientific methods to evaluate the effectiveness of intervention and prevention programs; enhancing the knowledge base about risk and protective factors and the consequences of suicidal behavior; and continuing to improve methods for data collection in order to describe and track suicidal behaviors. The NCIPC Internet site is http://www.cdc.gov/injury.
The Indian Health Service (IHS) supports suicide prevention activities through consultation and technical assistance to tribes through 12 Area Offices. Additionally, IHS operates nine regional alcohol and substance abuse treatment centers for youth 12-18 years of age (see http://www.ihs.gov). Reports on the prevalence of various markers of Indian health by region, including suicide mortality, are available at http://www.ihs.gov/publicinfo/publications/index.asp.
Health Resources and Services Administration supports suicide prevention activities through the Bureau of Primary Health Care, the HIV AIDS Bureau, Maternal and Child Health Bureau (MCHB), and Office of Rural Health Policy (see http://www.hrsa.gov). The MCHB provided funding for the Children's Safety Network that has developed youth suicide prevention activity inventories across various states (see http://www.childrenssafetynetwork.org/links/youthsp.asp).
See Section VIII, Other
Information - Required Federal Citations, for policies related to this
announcement.
Section II. Award Information
1.
Mechanism of Support
This FOA will use
the NIH Research Project Grant (R01) award mechanism. As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project. The total project period for an R01 application submitted in response
to this FOA may not exceed 5 years.
This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of meritorious applications.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible
Applicants
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
2. Cost Sharing or Matching
Cost sharing is not required. The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
Not applicable.
Section IV. Application and Submission Information
1. Address to Request Application
Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A.
Submission, Review and Anticipated Start Dates
Application
Submission Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm.
Peer Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm.
Council Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the NIH
Applications must be
prepared using the research grant application forms found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and five
signed photocopies in one package to:
Center for Scientific
Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C.
Application Processing
Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy
Statement (http://grants.nih.gov/grants/policy/policy.htm).
Pre-Award Costs are allowable. A grantee may, at
his/her own risk and without NIH prior approval, incur obligations and
expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new or competing continuation award if such costs:
are necessary to conduct the project, and would be allowable under the grant,
if awarded, without NIH prior approval. If specific expenditures would
otherwise require prior approval, the grantee must obtain NIH approval before
incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a
new or competing continuation award.
The incurrence of
pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Specific
Instructions for Modular Grant applications.
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.
Applicants requesting
$500,000 or more in direct costs for any year must carry out the following
steps:
1) Contact the IC
program staff at least 6 weeks before submitting the application, i.e., as you
are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award; and,
3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.
This policy applies to all investigator-initiated new
(type 1), competing continuation (type 2), competing supplement, or any amended
or revised version of these grant application types. Additional information on
this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
Applicants
requesting more than $500,000 in direct costs in any year of the proposed
research must include a plan for sharing research data in their application.
The funding organization will be responsible for monitoring the data sharing
policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
Sharing
Research Resources
NIH policy requires
that grant awardee recipients make unique research resources readily available
for research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications
submitted for this funding opportunity will be assigned to the ICs on the basis
of established PHS referral guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures http://www.csr.nih.gov/refrev.htm
will evaluate applications for scientific and technical merit.
As part of the
initial merit review, all applications will:
The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our
understanding of biological systems, to improve the control of disease, and to
enhance health. In their written critiques, reviewers will be asked to comment
on each of the following criteria in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these goals.
Each of these criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application. Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Significance: Does this study address an
important problem? If the aims of the application are achieved, how will scientific
knowledge or clinical practice be advanced? What will be the effect of these
studies on the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
2.A. Additional Review
Criteria:
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Protection of Human Subjects from Research
Risk: The involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed (see the
Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan, Section E on Human Subjects in
the PHS Form 398).
Care and
Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional
Review Considerations
Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed research
may be assessed by the reviewers. The priority score should not be affected by
the evaluation of the budget.
2.C. Sharing
Research Data
The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score. The presence of a data
sharing plan will be part of the terms and conditions of the award. The funding
organization will be responsible for monitoring the data sharing policy.
2.D. Sharing
Research Resources
NIH policy requires that grant awardee recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr.
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the administrative
review of each Non-Competing
Grant Progress Report (PHS 2590), See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable.
Section VI. Award Administration Information
1. Award
Notices
After the peer review of the application is completed,
the PD/PI will be able to access his or her Summary Statement (written
critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions
of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the signing official shown on the
electronic application.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and
National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS
Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency
Contacts
We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues:
1. Scientific/Research Contacts:
Jane L. Pearson, Ph.D.
Chair, Suicide Research Consortium
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC
9635
Bethesda, MD 20892-9635
Telephone: (301) 443-3598
FAX: (301) 594-6784
Email: [email protected]
James D. Colliver, PhD
Division of Epidemiology, Services and Prevention
Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5144, MSC 9589
Bethesda, Maryland 20892-9589
Telephone: (301) 435-1329
FAX: (301) 443-2636
Email: [email protected]
Page Chiapella, Ph.D.
Division of Treatment and Recovery
Research
National Institute on Alcohol Abuse
and Alcoholism
5635 Fishers Lane, Suite 2044, MSC 9304
Bethesda, MD 20892-9304
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-4715
FAX: (301) 443-8774
Email: [email protected]
2. Peer
Review Contacts:
Not applicable.
3. Financial or Grants Management Contacts:
Rebecca Claycamp, M.S., CRA
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard,
Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
FAX: (301) 443-6885
Email: [email protected]
Catherine Mills
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6847
Email: [email protected]
Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-4704
Email: [email protected]
Section VIII. Other Information
Required
Federal Citations
Use of Animals in Research:
Recipients of PHS
support for activities involving live, vertebrate animals must comply with PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Access to Research Data through the Freedom of
Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model Organisms:
NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants
Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications where
the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R); and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject
Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for
federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information," the "Privacy Rule," on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
Website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be
self-contained within specified page limitations. Unless otherwise specified in
an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
FOA is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The NIH Grants Policy Statement
can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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